Senior Regulatory Associate - Hertfordshire - ASAP

A global Pharmaceutical client of mine is currently looking for a Senior Regulatory Associate to join them on a permanent basis at their site in Hertfordshire.

Main Responsibilities:

• Connect, collaborate and communicate with internal and external customers to achieve business goals
• Member of a dedicated Regulatory team managing safety updates to product information for the European generic portfolio
• Authoring and maintenance of the SmPC, Package Leaflet (PL) and Labelling in compliance with the reference product, other safety information, CMC and relevant Labelling legislation and guidelines
• Responding to questions and requests from European health authorities and the EMA
• Supporting the Central Regulatory team with submission-ready documents and strategy

Key Requirements:

• Experience in Regulatory affairs, preferably including management of Labelling documents
• Knowledge of the life cycle and maintenance of product information
• Understanding of key legislation, templates and guidelines governing Labelling within Europe
• Proficiency in speaking, comprehending, reading and writing English

Vacancy Summary:

Job Type: Permanent

Location: Hertfordshire

Salary: Negotiable (DOE)

If you are interested in this role or know anyone who might be please forward on an up to date CV ASAP and I will be in touch shortly to discuss setting up an interview.